Sanofi's Sarclisa Combination Therapy has Significant Efficacy in the Treatment of Multiple Myeloma

Recently, Sanofi announced the latest results of the Phase 3 IKEMA clinical trial. The trial is evaluating the addition of the CD38-targeting antibody Sarclisa (isatuximab) to the proteasome inhibitor Kyprolis (carfilzomib, cardinal) in patients with relapsed multiple myeloma (MM) who have received 1-3 prior anti-myeloma therapies Efficacy and safety of a combination regimen (Kd) of filzomib) and dexamethasone.

The median progression-free survival (mPFS) was 19.2 months (95% CI: 15.8-25.1; n=123) in the Kd-treated group and 35.7 months in the Sarclisa+Kd-treated group (HR). = 0.58; 95% CI: 25.8-44.0; n = 179). This result represents the longest mPFS observed in a clinical study investigating a proteasome inhibitor backbone therapy in second-line treatment of relapsed MM.

A PFS analysis based on the US FDA recommendation on censoring rules (applicable to approved US prescribing information) showed mPFS of 20.8 months in the Kd treatment group and 41.7 months in the Sarclisa+Kd treatment group (HR= 0.59; 95% CI: 27.1 - not computable [NC]).

The median time to next treatment (TTNT) was 25 months (95% CI: 17.9-31.3) in the Kd treatment group and 44.9 months in the Sarclisa+Kd treatment group (HR = 0.55; 95 %CI: 31.6-NC). TTNT measures the time interval from the date of randomization to the date of the start of the next treatment, allowing a measure of the treatment benefit period.

The safety and tolerability profile of Sarclisa observed in this analysis was consistent with the safety profile of Sarclisa in other clinical trials, and no new safety signals were observed.

Sarclisa is a monoclonal antibody drug that targets a specific epitope on the CD38 receptor on multiple myeloma cells. Sarclisa launched in 2020 and is currently approved in several countries including the US and EU countries.

In the field of MM, Sarclisa is nearly 5 years later than the CD38 antibody drug Darzalex (Zhaoke®, daratumumab, daratumumab), which is a competing product from Johnson & Johnson. Darzalex went public in 2015 and has global sales of $6.023 billion in 2021. By comparison, Sarclisa's sales in 2021 will be just 176 million euros.